Treatment of Subepithelial Infiltrates Secondary to Epidemic Keratoconjunctivitis: Corticosteroids Versus Cyclosporine Eyedrops: A Randomized Double-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Mean change from baseline in subepithelial infiltrates number
研究概览
简要总结
Purpose:
To compare efficiency and tolerance between topical 0.5% cyclosporine A and fluorometholone in patients with subepithelial corneal infiltrates (SEIs).
Methods :
A prospective double-blind randomized study was conducted involving 72 eyes, 38 treated with topical fluorometholone and 34 eyes treated with cyclosporine A 0.5% eyedrops, having SEIs. Treatment was considered successful if there was reduction of SEIs and improvement in visual acuity (two snellen lines). Tolerance was mainly evaluated by Schirmer test, conjunctival hyperemia and burning sensation upon eyedrops instillation.
详细描述
This study was performed on the 72 eyes of 51 patients who were referred to our clinics for epidemic keratoconjunctivitis (EKC).Diagnosis of EKC was based on the constellation of clinical features. The investigators conducted a double-blind randomized prospective parallel trial involving : 38 patients treated with topical fluorometholone and 34 eyes treated with cyclosporine A 0.5% eye drops. Cyclosporine A eye drops were prepared in Ricin oil by the pharmacy of Tunis Military Hospital. The sample size was measured by our research department, to obtain a conclusion of non-inferiority of cyclosporine A compared to fluorometholone in the chronic phase of EKC.
Duration of the whole regimen was six months. The study included an extra month after the end of the regimen. It was called " wash-out ". Patients who had less than one month of treatment or an uncontrolled treatment side effect or who presented a degenerative iron line were excluded from the rest of the regimen.The regimen was the same for both treatments in order to preserve the double-blind characteristic : 4 times a day for one month then 3 times a day for one month and 2 times a day for four months.
Patients were examined on admission to the study and one month , three months, six months and seven months after the onset of treatment. The investigators followed a double-masked fashion in all the phases of the study.
Information gathered in M0 included basic demographic information (age and sex), medical and ophtalmological history, involved eye(s) and duration of symptoms in the acute episode. The investigators evaluated and recorded the interval of time between the onset of the infection and the beginning of the trial and called it " pretherapeutic period ". At each visit, SEIs were photo-documented, best corrected visual acuity (converted to mean logarithm of the minimum angle of resolution), spheric equivalent, SEIs number, intraocular pressure (with non contact tonometers), break-up time and Schimer test type 1 and cup/disc score were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The allocation sequence of the treatment was generated by chance and concealed until all the study was over and all outcomes were assessed. Consecutive patients with subepithelial infiltrates were randomly allocated to one of the two groups by a parallel assignment (1:1).
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients having subepithelial infiltrates following epidemic keratoconjunctivites persisting for 14 days or more
排除标准
- •a past history of glaucoma or other anterior or posterior segment disease or surgery
- •a chronic use of topical or systemic medications
- •pregnancy,
- •contact lens wearers,
- •patients who couldn't attend at least two regimen visits
研究组 & 干预措施
Fluorometholone group
This group included 38 patients treated with topical fluorometholone 0.1% (FLUCON®) 4 times a day for one month then 3 times a day for one month and 2 times a day for four months.
干预措施: FLUCON® (Drug)
Cyclosporine A group
This group included 34 patients treated with cyclosporine A 0.5% eye drops prepared in Ricin oil by the pharmacy of Tunis Military Hospital and prescribed 4 times a day for one month then 3 times a day for one month and 2 times a day for four months.
干预措施: Cyclosporine A eye drops 0.5% (Drug)
结局指标
主要结局
Mean change from baseline in subepithelial infiltrates number
时间窗: day 0, Month 1, Month 3, Month 6, Month 7
The subepithelial infiltrates were counted at baseline and at each control visit.The mean change was then calculated between each two visits. Treatment was considrerd efficient if the subepithelial infiltrates decreased half the baseline number or completely disappeared.
Mean change from baseline in Schirmer type 1 value
时间窗: day 0, Month 1, Month 3, Month 6, Month 7
The Schirmer value was assessed without local anesthesia. Treatment was considered efficient with a good tolerance when the schirmer type 1 was superior than 5ml/5min.
次要结局
- Mean change from baseline in best corrected visual acuity(day 0, Month 1, Month 3, Month 6)
- Mean change from baseline in spheric equivalent(day 0, Month 6)
- Mean change from baseline in clinical score(day 0, Month 1, Month 3, Month 6)
- Overall satisfaction with treatment subjective evaluation: scale(Month 7)
- Number of participants with burning sensation upon eyedrops instillation(day 0, Month 1, Month 3, Month 6)
- Mean change from baseline in intraocular pressure(day 0, Month 1, Month 3, Month 6)
- Number of participants with appearance of lens opacification and corneal ulcer or superinfection(up to six months)
研究者
Asma Khallouli
Teaching hospital assistant lecturer in ophthalmology and a member in the research committee of the military hospital of Tunis
Military Hospital of Tunis